Understanding Neonatal Jaundice in Rwanda

This study exploits the distribution of low-cost high-quality phototherapy devices (Brilliance by D-Rev) to public hospitals in Rwanda to assess whether the provision of improved technology improves health care for infant jaundice. Specifically, the investigators are interested in measuring whether the provision of an additional high-quality phototherapy device, a known effective treatment for jaundice, successfully translates into improved care of neonatal jaundice in Rwanda where the burden of jaundice is particularly high.

Study Overview

• Status: Completed
• Conditions: Jaundice, Neonatal
• Intervention / Treatment: Device: Brilliance

Detailed Description

The Ministry of Health (MIH) in Rwanda has planned to provide Brilliance devices (phototherapy) to 46 public hospitals in Rwanda. The investigators have worked with MIH to have the delivery of these machines be staggered over three phases through random selection. The methodology relies on the staggered distribution of Brilliance devices and survey data collected prior and during delivery dates to evaluate the provision of low-cost high quality phototherapy machines, following the basic design of a staggered randomized controlled trial. Specifically, the investigators will survey all hospitals prior to the receipt of any Brilliance devices to provide a baseline description of the care received in these facilities. These surveys will collect information on the facility itself, including average infant jaundice caseloads and descriptions of recent cases. The investigators will then randomly select 15 hospitals to receive the Brilliance units. Three months after installation of Brilliance has occurred at these facilities (Group 1), another randomly selected subset of 16 facilities (Group 2) will receive their Brilliance machines. Three months after these installations have been completed, the remaining facilities (Group 3) will receive their Brilliance machines. During this period, there will be ongoing data collection from the hospitals, creating a panel dataset on the jaundice-related caseloads at these facilities. The data collected will be akin to collecting hospital records of patients diagnosed with jaundice, but no identifiable patient information will be collected.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • Kigali, Rwanda
    • University Central Hospital of Kigali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• For patient level record (de-identified), diagnosed by the facility for having infant jaundice
• The facilities are included based on selection by the Ministry of Health for receiving additional phototherapy machines.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Phase 1; This is the first set of randomly selected hospitals to receive the intervention (Brilliance device). The intervention to be provided is the phototherapy device, Brilliance. *No individual participants are recruited for this study.	Device: Brilliance; The intervention is the provision of the Brilliance phototherapy machines to hospitals. This device is to be provided to facilities regardless of the study -- the study's involvement has been to collaborate with the Ministry of Health so that Brilliance is distributed in a randomized staggered method. In that sense, the study may be considered observational, as the study is not driving whether or not a hospital receives Brilliance, only when it receives Brilliance in a short time frame.
ACTIVE_COMPARATOR: Phase 2; This is the second set of hospitals to receive the device. For the first three months, they receive no intervention, after which they become part of the "active comparator" arm. The intervention to be provided is the phototherapy device, Brilliance. *No individual participants are recruited for this study.	Device: Brilliance; The intervention is the provision of the Brilliance phototherapy machines to hospitals. This device is to be provided to facilities regardless of the study -- the study's involvement has been to collaborate with the Ministry of Health so that Brilliance is distributed in a randomized staggered method. In that sense, the study may be considered observational, as the study is not driving whether or not a hospital receives Brilliance, only when it receives Brilliance in a short time frame.
NO_INTERVENTION: Phase 3; This is the last set of hospitals to receive the device. For the first six months, they receive no intervention, after which the study is completed and they are given the device Brilliance. *No individual participants are recruited for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of treatment for infant jaundice	Number of hours infant diagnosed with jaundice is provided phototherapy (PT). This is calculated by subtracting the age at which the patient is first given PT from the age at which the patient is removed from PT. The analysis is conditional on the subset of infants diagnosed with jaundice.	Through study completion, an average of 9 months
Length of hospital duration for infant jaundice	This is measured by the duration of stay at the facility, as measured by the time between being admitted and being discharged. The analysis is conditional on the subset of infants diagnosed with jaundice.	Through study completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased rate of reduction in bilirubin	Using different measures of estimated bilirubin levels for one patient and the age at which those tests were provided, we will estimate the change in bilirubin levels over the change in age (by hours) as the rate of reduction in bilirubin levels. This assumes that age at diagnosis is similar across treatment arms. If this is not the case or if our estimates are not precise, we will use maximum bilirubin levels recorded as a proxy. The analysis is conditional on the subset of infants diagnosed with jaundice.	Through study completion, an average of 9 months
Improved Treatment of Jaundice	An indicator variable for whether the patient was treated at the facility (as opposed to being referred elsewhere for treatment).	Through study completion, an average of 9 months
Improved Treatment of Jaundice By Not Being Referred Elsewhere	An indicator variable for whether the patient was treated at the facility (as opposed to being referred elsewhere for treatment).	Through study completion, an average of 9 months
Improved Treatment of Jaundice by Receiving Phototherapy	An indicator variable for whether the patient received phototherapy.	Through study completion, an average of 9 months
Improved Treatment of Jaundice by Not Sharing Phototherapy	An indicator variable for whether the patient did not share a phototherapy machine with another infant	Through study completion, an average of 9 months
Improved Treatment of Jaundice by Using Single Phototherapy Device	An indicator variable for whether the patient used multiple phototherapy machines;	Through study completion, an average of 9 months
Improved Treatment of Jaundice by Reducing Exchange Transfusions	An indicator variable for whether the patient received an exchange transfusion	Through study completion, an average of 9 months
Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion	An indicator variable for whether the patient reached the threshold for exchange transfusion	Through study completion, an average of 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age at time of jaundice diagnosis	Average age of infant at the time of jaundice diagnosis	Through study completion, an average of 9 months
Jaundice diagnosis rates	Rate of infant jaundice diagnoses per month per admitted infants as reported by hospital facility	Through study completion, an average of 9 months
Jaundice diagnosis levels	Number of infant jaundice diagnoses per month as reported by the hospital facility	Through study completion, an average of 9 months
Fee Charged	Reduction in cost of jaundice case (fee charged and amount earned by facility per diagnosed jaundice patient) as reported by hospital facility.	Through study completion, an average of 9 months
Increased technical capacity by Number of Phototherapy Devices	Number of Phototherapy machines at facility	Through study completion, an average of 9 months
Increased technical capacity by Number of Operational Phototherapy Devices	Number of operational phototherapy machines at facility	Through study completion, an average of 9 months
Increased technical capacity by Improved Irradiance Levels	Average irradiance levels of phototherapy machines at the hospital facility	Through study completion, an average of 9 months

Collaborators and Investigators

• Sponsor: University of California, Merced
• Collaborators: Ministry of Health, Rwanda; Rwanda Pediatric Association; Rwanda Bio-Medical Center; Child Relief International; D-Rev
• Investigators: Principal Investigator: Ketki Sheth, PhD, University of California, Merced; Principal Investigator: Lisine Tuysenge, MD, Rwanda Pediatric Association

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 29, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: FWA Assurance No: 00001973

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All IPD collected will be anonymized and aggregated for analysis. The anonymized information will be shared publicly if permission from the Rwandan Ministry of Health is granted.

Study Data/Documents

1. Statistical Analysis Plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No